ClinicalTrials.gg
Active, not recruitingNCT05125965MEDIIMYOUpdated May 1, 2026

Contribution of Cardiac MRI in the Early Diagnosis of Myocarditis Induced by Immunotherapy

An interventional study of additional time for the MRI in Myocarditis, sponsored by Centre Chirurgical Marie Lannelongue. Active, not recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by Centre Chirurgical Marie Lannelongue · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

Anti-cancer immunotherapy, one of the therapeutic revolutions of recent years. It is based on the use of antibodies that block immune system checkpoints that have been hijacked by cancer cells to benefit themselves. Blocking these checkpoints, such as PD-1, unleashes the action of anti-cancer T cells that can then destroy the tumor. The efficacy of these targeted therapies is significant, with an average 40% response rate in patients with metastatic cancers.Immune checkpoint inhibitors (ICIs) are becoming a 1st line therapy in many oncology indications due to their therapeutic line in many oncology indications due to their favorable effect on the prognosis of various prognosis of various cancers Since checkpoints play a key role in controlling the intensity and duration of an immune response, their immune response, therefore, their inhibition exposes to adverse inflammatory or autoimmune effects inflammatory or autoimmune adverse effects that can be severe and sometimes lethal.Most side effects of ICIs occur within the first few months after initiation of treatment. The toxicity of immunotherapy is immunological, all organs including the heart can be including the heart, can be affected.

Cardiac autoimmune involvement in ICIs can involve the myocardium, pericardium, and/or vascular endothelium. These entities may be interrelated or, on the contrary, isolated.

In the last 5 years, the number of described cases of myocarditis associated with ICIstreatment has increased. Their incidence remains low, estimated between 0.5 and 2%. This probably represents the most serious cardiovascular complication, as the mortality attributed to it reaches almost 50%.

In recent years MRI has become very important in the noninvasive diagnosis of acute myocarditis. The latest update of the Lake Louise criteria in 2018 has thus confirmed cardiac MRI in its first place among noninvasive examinations for the diagnosis of myocarditis with a sensitivity of 87.5%, a specificity of 96.2%, and a positive predictive value of 97.2%.

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Conditions studied

  • Myocarditis

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Keywords

  • anti-cancer immunotherapy
  • cardiac autoimmune diseases
  • Myocarditis
03

In context

Myocarditis

174 studies on the registry are indexed under Myocarditis; 75 are open to participants now.

This study's planned enrollment of 200 is above the median of 80 across 53 interventional studies indexed under Myocarditis.

Browse Myocarditis studies →

Lead sponsor

Centre Chirurgical Marie Lannelongue is the lead sponsor of 40 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing immunotherapy with an indication for cardiac MRI for suspected myocarditis or other cardiovascular complications
  • Patient over 18 years of age
  • Patient affiliated to a health insurance plan
  • Patient who has given free, informed and oral consent

Exclusion criteria

Exclusion Criteria:

  • to immunotherapy
  • Pregnant or breastfeeding patient (if applicable)
  • Contraindication to cardiac MRI
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Patient undergoing immunotherapy with an indication for cardiac MRI

    Patient undergoing immunotherapy with an indication for cardiac MRI for suspected myocarditis or myocarditis or other cardiovascular complications

    Other: additional time for the MRI

Interventions

  • Otheradditional time for the MRI

    3 additional minutes to perform the MRI

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What researchers measure

Primary outcomes

  1. cardiac MRI

    ejection fraction

    Time frame: 1 day

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Study locations

3 sites
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05125965
Lead sponsor
Centre Chirurgical Marie Lannelongue
Responsible party
Sponsor
First posted
Nov 18, 2021
Start date
Nov 15, 2021
Primary completion
Apr 1, 2026
Completion
Apr 1, 2027 (estimated)
Last update
May 1, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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